Back to resultsVisual Function After Implantation of AcrySof® Toric Lens
Primary Purpose
Cataract
Status
Terminated
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
AcrySof Toric Intraocular Lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract
Eligibility Criteria
Inclusion Criteria:
- Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
- Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
- All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
- For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.
Exclusion Criteria:
- Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
- AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Toric
Arm Description
AcrySof Toric Intraocular Lens (IOL)
Outcomes
Primary Outcome Measures
Postoperative Refractive Cylinder
Secondary Outcome Measures
Uncorrected distance visual acuity (UCDVA)
Best corrected distance visual acuity (BDCVA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01074606
Brief Title
Visual Function After Implantation of AcrySof® Toric Lens
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated based on a business decision.
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toric
Arm Type
Experimental
Arm Description
AcrySof Toric Intraocular Lens (IOL)
Intervention Type
Device
Intervention Name(s)
AcrySof Toric Intraocular Lens
Intervention Description
Implantation of the AcrySof Toric Intraocular Lens (IOL)
Primary Outcome Measure Information:
Title
Postoperative Refractive Cylinder
Time Frame
Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Secondary Outcome Measure Information:
Title
Uncorrected distance visual acuity (UCDVA)
Time Frame
Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Title
Best corrected distance visual acuity (BDCVA)
Time Frame
Pre-operative, 1 month postoperative, 3 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.
Exclusion Criteria:
Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
Facility Information:
City
Changhua City
ZIP/Postal Code
500
Country
Taiwan
12. IPD Sharing Statement
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Visual Function After Implantation of AcrySof® Toric Lens
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